Viral clearance studies in BSLII and BSLIII certified cell and virus laboratories
Virus risk assessment analysis and reporting
Flexible study date – performed by viral clearance testing experts
Validated measurements of both DNA and RNA viruses using ddPCR
Viral clearance studies and risk assessments
dPCR service provider
Vironova Biosafety is a contract research organization (CRO) specialized in viral clearance studies for biological drugs.
We offer viral clearance studies in BSLII and BSLIII certified cell and virus laboratories, in compliance with good laboratory practice (GLP) principles and are GLP certified since 2011. Our services range from early R&D to market release. Literature-based viral risk assessment is also offered by our experts with extensive scientific and regulatory experience.
Our office and laboratories are in central Stockholm. Our customers are found worldwide.
Viral clearance is performed before Phase I and Phase III clinical trials. For the early phase, testing should be performed with one enveloped virus (preferable a retrovirus) and one small non-enveloped model virus.
Our risk assesment experts assist you with consultative services regarding viral safety, such as: viral risk assessment reports, advice on viral reduction strategies, down-scaling strategies, and on regulatory requirements
PCR is a method where a specific DNA sequence, the target, is amplified by a primer pair. The amplification can be detected by a sequence specific probe coupled to a fluorofor and its quencher.
Vironova Biosafety operates in compliance with OECD GLP guidelines and is included in the regular inspection plan of the Swedish Board for Accreditation and Conformity Assessment (SWEDAC).
As stated in ICH Q5A, manufacturers of biologics are required to prove the viral removal and/or inactivation efficacy in their manufacturing process, and viral clearance studies are required to be performed in compliance with GLP principles.